| 원저 : 유전자재조합 B형 간염바이러스 백신 ( HG -Ⅱ ) 의 면역원성 및 안전성 ( Original Articles : Immunogenicity and Safety of a 20 ㎍ Dose of the Green Cross Recombinant Hepatitis B Vaccine ( HG -Ⅱ ) in Healthy Adults ) |
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| Immunogenicity and Safety of a 20 ㎍ Dose of the Green Cross Recombinant Hepatitis B Vaccine (HG -Ⅱ) in Healthy Adults |
| Kye Heui Lee , Ok Jae Lee , Young Chai Kim , Ran Namgung , Young Mo Sohn |
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| ABSTRACT |
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Background/Aims
. The introduction of Hansenula polymorpha for recombinant hepatitis B vaccine production allowed high product yield with plasmid stability and less glycosylation than conventional Saccharomyces cerevisiae system. A Green Cross HG-II vaccine formulated from HBsAg produced by a recombinant strain of the yeast H. polymorpha was evaluated for immunogenicity and safety in an open label triaL Methods ' A 20 ug dose of Green Cross HG-II vaccine was administered intramuscularly at 0, 1 and 6 months at the deltoid region in 118 healthy adults seronegative for HBV markers. The anti-HBs titers were determined at one month after administration of the third dose of vaccine by radioimmunoassay. Results .' The seroconversion rate was 96.8% (90 out of 93), with seroprotective rate of 95.7% (89 out of 93). The geometric mean titers(GMT) of the anti-HBs response was 153.1mIU/ml in seroconverters. An age-dependent effect was observed in the anti-HBs response. But sex-dependent effect was not prominent. Reactogenecity was in incidence and general reactions were short-lasting and a mainly mild in severity. Conclusions .' The results of this study have shown that the Green Cross HG-II vaccine is safe and clinically well tolerated, a nd that it may provide protection against HBV infection. |
| KeyWords:
Recombinant Hepatitis B Vaccine , Hansenula polymorpha system |
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